• An Exciting Time in Life Sciences: Touching Stories from a Life-Improving Industry

    29 June, 2017 by Marci Crane, Staff Writer, MasterControl

    A recent industry outlook for the life sciences industry published by Deloitte mentions opportunities and concerns facing the life sciences industry.

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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 by Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

     At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines

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  • The Quality Metrics Journey

    15 June, 2017 by Susan Schniepp, Fellow, Regulatory Compliance Associates Inc

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

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  • Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

    8 June, 2017 by Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.

    While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?

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  • Why It’s Time to Revisit FDA’s Quality by Design

    1 June, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.

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  • When GCP & GMP Meet

    30 May, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • Keeping Up With the Top Pharma Industry Trends of 2017

    18 May, 2017 James Jardine, Staff Writer, MasterControl

    A close look at the key trends that will have the biggest impact on the pharmaceutical industry this year.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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  • Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • 10 Criteria to Aid in the Selection of Investigative Sites

    2 May, 2017 by Craig Morgan, Head of Marketing, goBalto

    Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

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  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    27 April, 2017 by Drew Locher, President, Change Management Associates

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    24 April, 2017 Cindy Fazzi, Staff Writer, MasterControl

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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  • Site Selection: Don’t Forget About the Study Drug

    13 April, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient data

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  • 4 Rules for Building an eClinical Qualification Framework

    6 April, 2017 by Rob Sims, Marketing Programs Manager, UL

    As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/di

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  • How to Practice Quality Management in Your Personal Life

    4 April, 2017 Paul Sanderson, Solutions Consultants Manager, MasterControl

    “Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

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  • FDA Guidance Answers Questions Regarding Data Integrity

    23 March, 2017 by David Jensen, Staff Writer, MasterControl

    An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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  • Brave New World: The Mutual Recognition of CGMP Inspections

    9 March, 2017 by Mark I. Schwartz, Director, Hyman, Phelps & McNamara PC

    Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see

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  • The Data Driven Reality of Clinical Trials

    7 March, 2017 by Craig Morgan, Head of Marketing, goBalto

    Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.

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